Cardio Flow Peripheral Guide Wire GW1001
Cardio Flow Peripheral Guide Wire GW1001 is a Class II device made by Cardio Flow Inc.,, cleared under FDA 510(k) K213834 on 18 Mar 2022 and listed in FDA GUDID since 21 Jun 2024 (UDI-DI 00850040691009), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850040691009 | Date21 Jun 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213834 | Date18 Mar 2022 | StatusActive |
Official records
- AccessGUDID record 00850040691009
- FDA 510(k) database K213834
Across registries
- FDA 510(k) K213834 decided 18 Mar 2022 Active
- FDA GUDID UDI-DI 00850040691009 listed 21 Jun 2024 Listed
Timeline
- Cleared FDA 510(k) K213834
- Listed FDA GUDID 00850040691009
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cardio Flow Peripheral Guide Wire
- Generic name
- Peripheral vascular guidewire, manual
- Model / reference
- GW1001
- Primary DI / UDI-DI
- 00850040691009
- 510(k) Number
- FDA product code
- DQX
- GMDN term
- Peripheral vascular guidewire, manual
- Device class
- Class II
- Regulation number
- 870.1330
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide
- Size
- Guidewire Length — 325 Centimeter